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Risk management Phase Risk assessment of GM plants What is the approval process for import of GMOs in the EU? 1. RESEARCH & DEVELOPMENT 9 years on average OBJECTIVE: Select the best performing plant with the lowest likelihood of adverse effects 2. Safety assessment REGULATORY DOSSIER COMPARATIVE ASSESSMENT: IS THE GM AS SAFE AS ITS CONVENTIONAL COUNTERPART? • Agronomic characteristics (yield, height, etc.) • Composition (compounds, nutrients, allergens, etc.) > Field trials : GM vs. non-GM • Phenotype (appearance) 3. EFSA review SCIENTIFIC OPINION > EFSA declares the GM product safe EVALUATION OF RISK FOR HEALTH AND ENVIRONMENT During this process applicants are often asked to provide more information for clarification 2 opportunities selected 19 months on average 29 months on average UP TO 2 years DRAFT PROPOSAL FOR AUTHORISATION Draft SAFE! R R R After approval applicants are obliged to monitor and report any potential adverse effects on the environment R 6 PRINCIPLES RISK ASSESSMENT • Science-based • Case by case analysis • Precautionary principle • History of safe usage/consumption (include lessons learned from the past) • Compliance with interna- tional quality standards (OECD, ISO, GLP) • Weight of evidence approach AUTHORISATION BY EUROPEAN COMMISSION R 1000 opportunities identified POTENTIAL ENVIRONMENTAL IMPACT > Evaluate potential adverse effects on the environment MOLECULAR CHARACTERISATION > What DNA was put into the crop? > How many genes were put into the crop? > Where in the host genome is the inserted DNA located? > Is expression of the gene(s) stable? > Characterize the insert on molecular level or analyse the product on a molecular level, such as location and stability of the inserted gene, the number of genes inserted, etc. FOOD/FEED SAFETY > Testing on animals • Rats : 90 days of feeding to rule out adverse effects > Digestibility study The introduced protein is exposed to enzymes present in gastric and intestinal fluids > Bioinformatic analysis Do new compounds or altered levels of compounds in GM show similarities with known toxins or allergens ? > Animal feeding trials • Chickens: 42 days of feeding for nutritional assessment in case of compositional changes case-by-case R + + + If the product is found to be as safe as its conventional counterpart, the dossier is submitted to the European Food Safety Authority (EFSA) VOTING BY EU MEMBER STATES no yes NO CANCER NO MUTAGENESIS NO HEALTH CONCERNS NO MUT NO CANCER GENESIS A MUT TA NO CANCER GENESIS NO CANCER NO HEAL NO MUT TH HEAL LT GENESIS A MUT TA TH GENESIS CONCERNS NO HEAL CONCERNS TH HEAL LT CONCERNS TH
